Free Trial

atai Life Sciences (ATAI) FDA Events

atai Life Sciences logo
$2.66 +0.03 (+1.14%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$2.66 0.00 (0.00%)
As of 07:17 AM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for atai Life Sciences (ATAI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by atai Life Sciences (ATAI). Over the past two years, atai Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BPL-003, COMP360, ELE-101, EMP-01, and VLS-01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

atai Life Sciences' Drugs in FDA Review

BPL-003 - FDA Regulatory Timeline and Events

BPL-003 is a drug developed by atai Life Sciences for the following indication: In Patients With Treatment Resistant Depression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

COMP360 - FDA Regulatory Timeline and Events

COMP360 is a drug developed by atai Life Sciences for the following indication: Treatment-resistant depression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ELE-101 - FDA Regulatory Timeline and Events

ELE-101 is a drug developed by atai Life Sciences for the following indication: Treatment of mental health disorders. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

EMP-01 - FDA Regulatory Timeline and Events

EMP-01 is a drug developed by atai Life Sciences for the following indication: For the Treatment of Social Anxiety Disorder. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

VLS-01 - FDA Regulatory Timeline and Events

VLS-01 is a drug developed by atai Life Sciences for the following indication: For Treatment-Resistant Depression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

atai Life Sciences FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, atai Life Sciences (ATAI) has reported FDA regulatory activity for the following drugs: BPL-003, COMP360, EMP-01, VLS-01 and ELE-101.

The most recent FDA-related event for atai Life Sciences occurred on July 1, 2025, involving BPL-003. The update was categorized as "Top-line results," with the company reporting: "atai Life Sciences and Beckley Psytech Limited jointly announced positive topline results from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD)."

Current therapies from atai Life Sciences in review with the FDA target conditions such as:

  • In Patients With Treatment Resistant Depression - BPL-003
  • Treatment-resistant depression - COMP360
  • For the Treatment of Social Anxiety Disorder - EMP-01
  • For Treatment-Resistant Depression - VLS-01
  • Treatment of mental health disorders - ELE-101

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ATAI) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners